MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISTAL ATTACHMENT

Model Number	MH-588
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the article "quantification of interstitial cells of cajal and fibrosis during gastric per-oral endoscopic myotomy and its association with clinical outcomes." this was a prospective study of gastroparetic patients who underwent g-poem and intraprocedural pyloric muscle biopsies between january 2022 and april 2023.Type of adverse events/number of patients mucosotomy: 1 patient.This was adequately closed on the mucosal side with placement of two hemostatic clips.This report is related to the following linked patient identifiers: (b)(6).

• Brand Name: DISTAL ATTACHMENT
• Common Device Name: DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 19606294
• Report Number: 2429304-2024-0000312
• Device Sequence Number: 20392456
• Product Code: FDS
• UDI-Device Identifier: 04953170047879
• UDI-Public: 04953170047879
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2024
• Report Date (Section F): 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MH-588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE, GIF-H190; SINGLE USE ELECTROSURGICAL KNIFE, KD-611L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown